An Open Label Safety Study of Tipranavir Co-Administered With Low-Dose Ritonavir (TVP/r) in Patients With Advanced HIV-1 Infection and Limited Treatment Options

Brief Summary

This study evaluated the safety and tolerability of tipranavir to improve treatment options for HIV type 1-infected patients who have been previously treated and whose treatment is no longer effective.

Detailed Description

The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.

The occurrence of PI class-specific AEs, such as hemorrhage, dyslipidemia, hepatic events, hyperglycemia, pancreatitis, and rash.

The efficacy assessment will be performed by evaluating:

The quantity of HIV-1 RNA

The CD4 cell count.

Study Hypothesis:

The purpose of this open label study is to assess the safety and tolerability of tipranavir co-administered with low-dose ritonavir (500 mg tipranavir/200 mg ritonavir BID) in HIV-1 infected patients who are triple antiretroviral class experienced with at least two previous PI-containing regimens.